The EU Data Act (Regulation (EU) 2023/2854) has applied in full since 12 September 2025. According to Recital 14, medical and health devices clearly fall within the scope of the Act, including: medical devices (such as smart blood pressure monitors, blood glucose meters, ECG devices and implantable devices), digital health platforms and wearables, and services directly related to medical device functions (such as software that remotely adjusts medical device parameters).
For the medical sector, the transparency statement is based on Article 3(2) of the EU Data Act, which requires clear and comprehensible information to be provided to users before a contract for the purchase/lease of a product or related service is concluded. The original text:
[2. Before concluding a contract for the purchase, rent or lease of a connected product, the seller, rentor or lessor, which may be the manufacturer, shall provide at least the following information to the user, in a clear and comprehensible manner:
(a) the type, format and estimated volume of product data which the connected product is capable of generating;
(b) whether the connected product is capable of generating data continuously and in real-time;
(c) whether the connected product is capable of storing data on-device or on a remote server, including, where applicable, the intended duration of retention;
(d) how the user may access, retrieve or, where relevant, erase the data, including the technical means to do so, as well as their terms of use and quality of service]
The compliance framework for medical device transparency statements described above, in one chart:
There is no official template for the transparency statement. Here we present a practical “general-purpose” template suitable for most companies going global, for reference:
The above is a “general-purpose” EU Data Act transparency statement template. There is also a “platform-specific” type (e.g. for Amazon’s EU marketplaces); such simplified templates usually cover the legal basis, data types and data access:
The EU defines the “mandatory content” of the EU Data Act transparency statement only through the regulation and guidance, using the Data Act’s 7 modules as the framework (see the table above) to avoid restricting companies’ flexibility. Companies should also take the GDPR transparency requirements into account to ensure the content is compliant.
This is a series of educational articles introducing FDA, NMPA, GMP, CE MDR/IVDR and MDSAP regulations and standards.
Everbiz is happy to share medical device expertise with industry clients and hopes our extensive hands-on experience in quality systems and product registration will be of help to you.
Let’s contribute together to the development of the medical device industry. If you have any questions or requirements, please contact us.
Introduction to the ISO/IEC 27701 Standard
The Relationship Between ISO 27701 and Regulation (EU) 2016/679
Introduction to the GDPR (General Data Protection Regulation) for EU Medical Devices
EU Plans to Substantially Simplify the MDR: What Will Change for Certificates, Clinical Evidence and Notified Body Audits?
How Can Manufacturers Hedge Risk Through Insurance Under the MDR?
EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).
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